The US Food and Drug Administration (FDA) has granted fast track designation to Evaxion Biotech’s personalised cancer therapy, EVX-01, in combination with KEYTRUDA.
In December last year, Evaxion secured the FDA approval to advance with its Phase IIb clinical trial, where EVX-01 is given along with KEYTRUDA to patients with metastatic melanoma.
Furthermore, on 17 January 2023, Evaxion gained the fast-track designation for the vaccine candidate.
This fast-track designation will accelerate the regulatory body’s review of new drugs that showcase the potential to address an unmet medical requirement.
Evaxion CEO Per Norlén said: “We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate.”
Claimed to be Evaxion’s most advanced clinical asset, EVX-01 is a peptide-based cancer immunotherapy.
Under the programme, a unique drug is created for each patient based on gene analysis of their tumours as well as with their immune system. This process has become possible due to the company’s AI platform, PIONEER.
The ongoing Phase IIb study is carried out at clinical sites across the US, Europe, and Australia.
It is conducted in collaboration with Merck, which is supplying its PD-1 inhibitor KEYTRUDA.
The trial started in Australia with the enrolment of the first patient in September last year.